About this medication

What the medication is used for

ENDOCET is a combination product that contains two medications: oxycodone hydrochloride and acetaminophen. Acetaminophen belongs to the group of medications called analgesics (pain relievers) and antipyretics (fever reducers). Oxycodone belongs to the group of medications called narcotic analgesics. Oxycodone - acetaminophen is used to relieve moderate to moderately severe pain, including conditions associated with fever.

When it should not be used

You should not use ENDOCET if:

Your doctor did not prescribe it for you

You are allergic to oxycodone, acetaminophen, opioids or to any of the non-medicinal ingredients in the product (see What the nonmedicinal ingredients are)

Have a seizure disorder

Have preexisting respiratory depression

Have status asthmaticus (unresponsive asthma)

Your pain is mild

Your pain can be controlled by occasional use of any painkillers

You suffer from alcoholism

You have a head injury

You have a condition where the small bowel does not work properly (paralytic ileus) or you have severe pain in your abdomen

You are taking, or have taken within the past 2 weeks, a monoamine oxidase inhibitor medications (e.g., Nardil, Parnate)

You are taking any other products containing acetaminophen (e.g. TYLENOL)

What dosage forms it comes in

Warnings and precautions

Before you begin using ENDOCET be sure to inform your doctor or pharmacist of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication and will help your doctor to decide whether you should use ENDOCET and what extra care should be taken during its use.

DO NOT take with other products containing acetaminophen. Taking more than the maximum daily dose of acetaminophen may cause severe or possibly fatal liver damage.

BEFORE you use ENDOCET, talk to your doctor or pharmacist if you have, or had in the past any other medical conditions, especially the following ones:

trouble breathing or lung problems

head injury

kidney problems

liver problems. Acetaminophen can cause decreased liver function. People with liver disease or reduced liver function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

adrenal gland problems, such as Addison’s disease

convulsions or seizures

chronic alcoholism

hallucinations or other severe mental problems

past or present substance abuse or drug addiction.

You should take the following precautions while taking ENDOCET

You must not consume alcohol while taking ENDOCET, as it may increase the chance of experiencing dangerous side effects;

Driving or other tasks requiring full alertness should not be attempted until you are sure that taking ENDOCET does not make you drowsy

You must tell your doctor and pharmacist if you are taking any other medications, including natural health products, salicylates or other pain and fever relief medications (nonsteroidal anti-inflammatory drugs (NSAIDS)), or prescription medications - they will tell you what you should do. (see also section “Interactions With This Medication”)

If you are planning surgery, or about to undergo surgery, tell your doctor that you are taking ENDOCET.

Pregnancy

This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding

This medication passes into breast milk. If you are a breast-feeding mother and are taking oxycodone and acetaminophen, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children

The safety and effectiveness of using ENDOCET have not been established in children.

Dependence and withdrawal

This medication contains oxycodone. Physical dependence, psychological dependence, and abuse have occurred with the use of oxycodone. People with a history of past or current substance use problems may be at greater risk of developing abuse or addiction while taking this medication. Abuse is not a problem with people who require this medication for pain relief. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shaking, pain, nausea, tremors, diarrhea, and hallucinations. If you have been taking this medication for a while, it should be stopped gradually as directed by your doctor.

Acetaminophen can cause serious skin reactions that can spread to your mouth, lips, face, hands, trunk, arms and legs. This condition is life-threatening.

Liver Injury

Liver injury can occur when more than the maximum daily dose of acetaminophen is taken. Follow your doctor’s instructions to know how much acetaminophen you can take in a day. Acetaminophen can be in oral solutions/drops, syrup, pills, capsules, suppositories, intravenous solutions etc. To calculate how much acetaminophen you have had in a day, read the labels on all products to see if they contain acetaminophen. Keep track of how much acetaminophen is in each dose and how much you have taken in a 24 hour period.

Interactions with this medication

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take.

You should not take ENDOCET if you are currently taking (or recently stopped taking) one of the medicines known as monoamine oxidase inhibitor medications (e.g., Nardil, Parnate).

You should not take any other medications that contain acetaminophen (including over-the-counter preparations containing acetaminophen), or oxycodone while you are taking ENDOCET tablets.

Drugs that may interact with ENDOCET include:

Alcohol or other sedative drugs may enhance the drowsiness caused by oxycodone

Antihistamines or sleep aids (these medicines could make you drowsy and depress your breathing)

Any nonprescription, (over- the-counter) medications

Any herbal remedies

Proper use of this medication

The dosage varies according to each individual and can be affected by the severity of the pain as well as each person's response to the medication.

The usual recommended adult dose of ENDOCET (each tablet contains 5 mg oxycodone and 325 mg acetaminophen) is one tablet every 6 hours as needed for pain. ENDOCET is not recommended for people under 18 years of age.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

Discontinuation

This medication may be habit-forming if taken for long periods of time. Do not stop taking this medication without talking with your doctor. If this medication is stopped suddenly, you may experience withdrawal symptoms such as anxiety, sweating, trouble sleeping, shakiness, nausea, tremors, diarrhea, or hallucinations. If you plan on stopping the medication, your doctor may want you to reduce the dose gradually to reduce the severity of withdrawal effects.

Overdose

In case of drug overdosage, contact a healthcare practitioner (e.g. doctor) hospital emergency department or regional poison control centre, even if there are no symptoms. Within the first 24 hours you may experience increased sweating, nausea, vomiting, stomach pain, and loss of appetite.

Exceeding the recommendations by your doctor can result in respiratory depression (shallow, slow breathing), seizures, liver damage, coma, heart stoppage and death. Taking a significant overdose can result in hepatic toxicity.

Missed Dose

If you miss a dose, take it as soon as you remember. But, if it is almost time for the next dose, do not take the missed dose. Instead, take the next scheduled dose. Do not try to make up for the missed dose by taking a double dose next time.

Side effects and what to do about them

Most medications have some side effects; however, not all people have the same side effects, and some people experience few, if any, side effects.

When taking ENDOCET tablets the most common side effects include: nausea, vomiting, constipation, headache, dizziness, lightheadedness or feeling faint, mood changes and sleepiness.

Consult a doctor if:

you develop allergic reaction such as wheezing, rash or itching;

you have severe constipation

Stop taking the medication and seek immediate medical attention if any of the following occur:

convulsions (seizures)

signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

This is not a complete list of side effects. Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication or if you experience serious symptoms.

How to store it

ENDOCET tablets should be stored at room temperature (15oC to 30oC).

Do not use ENDOCET tablets after the expiry date. All expired medications should be returned to your pharmacist.

Keep this and all medicines in a safe place away from the sight and reach of children.

Reporting suspected side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

Postage paid labels, Canada Vigilance Reporting Form and the adverse reactions reporting guidelines are available on the MedEffecttm Canada Web site at www.healthcanada.gc.ca/medeffect.

Note: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This document, plus the Prescribing Information prepared for health professionals, can be found at www.bmscanada.ca or obtained by contacting the sponsor, Bristol-Myers Squibb Canada, at 1-866-463-6267.